ObesityBEDNCT02094027
Bariatric Surgery and Guided Self-help for Binge Eating Disorder
A study testing Guided Self Help and Treatment As Usual in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
To demonstrate the effectiveness of an easily administered intervention (guided self help) aimed at reducing binge eating in patients undergoing bariatric surgery. The investigators hypothesize that patients who have guided self help pre-operatively will have reduced episodes of bingeing pre-operatively compared to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Guided Self Help and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese (BMI >28 kg/m2)
- Pursuing bariatric surgery
Who cannot join
- Any illnesses which make the patient unsuitable
- If the patient is taking any medication which makes them unsuitable
- If the patient is pregnant or breast feeding
- If the patient has donated blood in the last three months
- If the patient has a history of alcoholism or substance dependency within the last 5 years
- If the patient has a history of major haematological, renal, gastrointestinal, hepatic, respiratory, cardiovascular or psychiatric disease or other illness or use of any medications, including over the counter products, which, in the opinion of the investigators would either interfere with the study or potentially cause harm to the volunteer
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- If the patient has any medical or psychological condition or social circumstances which would interfere with their ability to participate reliably in the trial
- If the patient is without access to a telephone
- If the patient is currently receiving or intends to receive treatment with an investigational drug within the next 2 months If the patient is currently receiving or intends to receive treatment for binge eating
- If the patient currently suffers with severe depression, as indicated by a Beck Depression Inventory Score greater than 28
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust
London, W6 8RF
About this study
Official title: The Role of Self-help in the Pre-surgical Treatment of Binge Eating Disorder in Bariatric Surgery Candidates: Implications for Weight-related and Psychological Outcome.
To demonstrate the effectiveness of an easily administered intervention (guided self help) aimed at reducing binge eating in patients undergoing bariatric surgery.
The investigators hypothesize that patients who have guided self help pre-operatively will have reduced episodes of bingeing pre-operatively compared to those having treatment as usual (bariatric surgery), which will be maintained in the post-operative period, and will be associated with improved weight loss and psychological outcomes after surgery.
Read the detailed description
Binge eating disorder (BED) is distressing and common in patients who present for treatment for obesity. Despite this, it is often undiagnosed. Patients who have bariatric surgery have improvements in their eating patterns, including binge eating. However there is variability in the degree of weight loss and post-operative complications following bariatric surgery, associated with disordered eating.
Guided self help for BED (GSH) is a treatment which, like bariatric surgery, is effective in reducing the number of binge episodes in people who binge eat. It is not known whether GSH prior to surgery, in patients undergoing bariatric surgery has any additional benefit for reducing bingeing, or improving weight loss in these patients.
- Conditions
- Obesity
- Being tested
- Guided Self Help, Treatment As Usual
- Keywords
- Obesity, Bariatric surgery, Binge eating, Self help
- Medical subject headings
- Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self HelpBehavioural
A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery
Treatment As UsualOther
Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating)
| Study group | Role | What they receive |
|---|---|---|
| Guided Self Help | Experimental | Guided Self Help intervention to reduce binge eating Receives: Behavioral: Guided Self Help |
| Treatment As Usual | Placebo comparator | No intervention for binge eating (treatment as usual in the form of bariatric surgery) Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index point
Measured: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Secondary outcomes (5)
Binge episodes
-Number of binge episodes per 28 days
Measured: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Complication or reversal of surgery
Surgical complication or reversal of bariatric surgery as per case notes
Measured: 3 month, 6 month and 1 year follow up
Quality of life
Score on SF-36, IQoL-lite, Hospital anxiety and depression scale (HADS), and PANAS (positive and negative affect scale)
Measured: baseline, pre-operative, 3 month, 6 month and 1 year follow up
Eating behaviour
Emotional, externally driven, disinhibited, restrained eating patterns and weight and shape concerns as measured by Eating disorders examination questionnaire (EDE-Q), Dutch Eating Behaviour Questionnaire (DEBQ), Three factor eating questionnaire (TFEQ)
Measured: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Drug and alcohol misuse
As measured by AUDIT drug and alcohol assessment tool
Measured: pre-operatively, baseline, 3 month, 6 month and 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: New evidence came to light to indicate that study was no longer relevant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Samantha Scholtz, MRCPsych, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094027
- Sponsor's protocol ID
- 10/H0707/67
- Acronym
- BED
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The IPD has been shared with Prof. Alex Blakemore as planned, who was conducting the genetic part of the study and who is using the data in wider analysis.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Self-help in the Pre-surgical Treatment of Binge Eating Disorder in Bariatric Surgery Candidates: Implications for Weight-related and Psychological Outcome.
- ClinicalTrials.gov ID
- NCT02094027
- Acronym / sponsor ID
- BED / 10/H0707/67
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Binge eating, Self help
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New evidence came to light to indicate that study was no longer relevant
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the effectiveness of an easily administered intervention (guided self help) aimed at reducing binge eating in patients undergoing bariatric surgery.
The investigators hypothesize that patients who have guided self help pre-operatively will have reduced episodes of bingeing pre-operatively compared to those having treatment as usual (bariatric surgery), which will be maintained in the post-operative period, and will be associated with improved weight loss and psychological outcomes after surgery.
Detailed description
Binge eating disorder (BED) is distressing and common in patients who present for treatment for obesity. Despite this, it is often undiagnosed. Patients who have bariatric surgery have improvements in their eating patterns, including binge eating. However there is variability in the degree of weight loss and post-operative complications following bariatric surgery, associated with disordered eating.
Guided self help for BED (GSH) is a treatment which, like bariatric surgery, is effective in reducing the number of binge episodes in people who binge eat. It is not known whether GSH prior to surgery, in patients undergoing bariatric surgery has any additional benefit for reducing bingeing, or improving weight loss in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Self Help | Experimental | Behavioral: Guided Self HelpGuided Self Help intervention to reduce binge eating |
| Treatment As Usual | Placebo comparator | Other: Treatment As UsualNo intervention for binge eating (treatment as usual in the form of bariatric surgery) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese (BMI >28 kg/m2)
- Pursuing bariatric surgery
Key exclusion criteria (10 listed)
- Any illnesses which make the patient unsuitable
- If the patient is taking any medication which makes them unsuitable
- If the patient is pregnant or breast feeding
- If the patient has donated blood in the last three months
- If the patient has a history of alcoholism or substance dependency within the last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self HelpA behaviourally orientated guided self help book designed to reduce binge eating prior to surgery | Behavioural | Guided Self Help |
| Treatment As UsualBinge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating) | Other | Treatment As Usual |
Primary outcome
Change in body mass index point
Time frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
5 secondary outcomes
Binge episodes
Time frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Complication or reversal of surgery
Time frame: 3 month, 6 month and 1 year follow up
Quality of life
Time frame: baseline, pre-operative, 3 month, 6 month and 1 year follow up
Eating behaviour
Time frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Drug and alcohol misuse
Time frame: pre-operatively, baseline, 3 month, 6 month and 1 year follow up
Results and safety
The study was stopped early (reason given: New evidence came to light to indicate that study was no longer relevant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: Yes. The IPD has been shared with Prof. Alex Blakemore as planned, who was conducting the genetic part of the study and who is using the data in wider analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Scholtz, MRCPsych principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self Help and Treatment As Usual in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: New evidence came to light to indicate that study was no longer relevant). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index point (time frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.